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FDA 510(k)

CROSSPOINT TRANSACCESS CATHETER

K-Number: K013363 · 2002-04-02

ApplicantTrans Vascular Incorporated
Decision Date2002-04-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CROSSPOINT TRANSACCESS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Trans Vascular Incorporated. It received FDA 510(k) clearance on 2002-04-02 under 510(k) number K013363. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSPOINT TRANSACCESS CATHETER?

CROSSPOINT TRANSACCESS CATHETER is a medical device that received FDA 510(k) clearance on 2002-04-02. The listed applicant is Trans Vascular Incorporated. The 510(k) number is K013363.

When did CROSSPOINT TRANSACCESS CATHETER receive FDA 510(k) clearance?

CROSSPOINT TRANSACCESS CATHETER received FDA 510(k) clearance on 2002-04-02, under 510(k) number K013363.

Who is the listed applicant for CROSSPOINT TRANSACCESS CATHETER?

The FDA 510(k) record lists Trans Vascular Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROSSPOINT TRANSACCESS CATHETER?

The FDA product code for CROSSPOINT TRANSACCESS CATHETER is ITX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trans Vascular Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031920CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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